Yesterday, Immucor Inc., a leader in transfusion and transplantation diagnostics that facilitate patient/donor compatibility held a press conference at AACC entitled ‘Ahead of the Curve in Transfusion Medicine: Driving a Paradigm Shift to Improve the Consistency and Quality of Care in the Age of Obamacare and Proposed FDA LDT Regulations.’ Speakers included Lakshman Ramamurthy, PhD, Avalere Health director of FDA Regulatory & Policy practice, who discussed recent changes in regulatory and reimbursement policy trends, including FDA RUO guidance and proposed LDT regulations. Immucor invited a special guest speaker Representative Danny Davis (D-Il-7), author of H.R.5124 – a bill introduced in the U.S. Congress on July 16, 2014, to amend the Public Health Service Act to reauthorize a sickle cell disease prevention and treatment demonstration program and to provide for sickle cell disease research, surveillance, prevention, and treatment.
Immucor’s PreciseType HEA test rapidly and accurately predicts blood compatibility between donors and patients to help prevent mismatches that can cause serious, potentially life- threatening reactions. The test works by detecting genes that govern the expression of 35 antigens that can appear on the surface of red blood cells.
Before the FDA approved the PreciseType HEA test, blood banks and transfusion centers had to rely on serology methods for RBC typing, or on laboratory developed and research-use-only tests – the turnaround time and complexity of which have made expansive antigen typing impractical and cost prohibitive.
Today, the first FDA-approved molecular test for RBC typing enables a new standard of care critical to the health outcomes of frequently transfused patients, such as those with sickle cell disease. Now, molecular donor/recipient matching can be the rule rather than the exception. Typing recipients before they receive their first transfusion and maintaining this profile in their health record to ensure a molecular-level donor-blood match could help avoid lifelong health consequences for patients. It could also save millions in hospital and other medical costs associated with serious transfusion reactions. Read more about the PreciseType HEA.
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